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NCT06137040EARLY_PHASE1Recruiting

Timely Administration of IV Magnesium Sulfate in Patients With a Moderate Asthma Exacerbation

University of Oklahoma

Start Date

11/30/2023

Completion Date

5/31/2025

Summary

This study aims to identify whether early administration of magnesium sulfate in moderate asthma exacerbations can potentially avoid admission, decrease length of stay in the emergency department (ED), decrease length of stay (LOS) in the general hospital floor vs pediatric intensive care unit (PICU), and decrease the need for respiratory support.

Detailed Description

Patients ages 5-17 presenting to the OU Children's Hospital Emergency Department from October 2023 to July 2024 will be assigned a respiratory score (RS) upon presentation. Those with a RS between 6-9 (moderate exacerbation) will be screened for inclusion. Eligible patient will then be approached for consent. First line asthma therapies including bronchodilators and steroids will not be delayed for the consent process. Patients who consent will be randomized to the control vs. experimental group once consent is obtained. The study will not be blinded once a patient is randomized to a group, the provider will know whether the patient will receive weight-based IV magnesium within the first hour (experimental group) or receive standard weight-based IV magnesium sulfate per the provider's clinical judgement (placebo group). Magnesium sulfate dosing for the experimental group will be as follows: 15-19 kg: 750 mg 20-29 kg: 1000 mg 30-39 kg: 1500 mg \>40 kg: 2000 mg Enrolled patients will have their clinical course reviewed and data obtained regarding LOS in ED and hospital stay, need for respiratory support, and or PICU LOS if applicable.

Eligibility Criteria

Age Range: 5 years to 17 years

Inclusion Criteria: * Ages 5-17 years old * Presents to the ED with a respiratory score in the "Moderate" range (6 * Parent(s)/Caregiver(s) speak English Exclusion Criteria: * Patients with chronic medical conditions including chronic pulmonary disease (other than asthma), cerebral palsy, congenital heart disease, tracheostomy dependent, myasthenia gravis patients * Patients who are pregnant * Parent(s)/Caregiver(s) do not speak English

Interventions

DRUG

Magnesium Sulfate within the first hour

OTHER

No Magnesium sulfate within the first hour

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Conditions

Asthma in ChildrenAsthma Attack

Locations

Oklahoma Children's Hospital

Oklahoma City, Oklahoma 73104

United States